MAUDE Adverse Event Report: SORIN GROUP USA, INC. REX HSP RALEIGH NC1; CUSTOM PERFUSION PACK

Model Number N/A

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 09/11/2015

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Sorin group received a report that the outlet port of the arterial filter snapped off while being manipulated by the user.This event occurred during priming, so there was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group received a report that the outlet port of the arterial filter snapped off while being manipulated by the user.This event occurred during priming, so there was no patient involvement.

Manufacturer Narrative

(b)(6).Sorin group received a report that the outlet port of the arterial filter snapped off while being manipulated by the user.This event occurred during priming, so there was no patient involvement.The filter was discarded by the customer so no product was returned for investigation, but a photograph of the arterial filter was taken and sent to sorin group usa for investigation.The received photograph shows the arterial filter bypass loop with the outlet port of the filter broken off.The photo is not detailed enough to determine if the filter had any specific defects or concerns relating to the solvent application, the port condition or the tubing attachment.This incident occurred while the user was attempting to push the tubing further onto the port by forcefully manipulating the connection in a circular motion.This type of manipulation of the connection, which is solvent bonded and zip tied, only serves to weaken the bond and can contribute to damage of the parts.A review of the device history record revealed no defects related to the nature of this complaint.A formal capa project (b)(4) has been initiated in response to this type of complaint.Photos received and evaluated.

• Brand Name: REX HSP RALEIGH NC1
• Type of Device: CUSTOM PERFUSION PACK
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 w. 65th way; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: carrie wood ; 14401 w 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5142610
• MDR Text Key: 28038877
• Report Number: 1718850-2015-00402
• Device Sequence Number: 1
• Product Code: OEZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 044002300
• Device Lot Number: 1515300161
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1